NDC Code(s) : 0591-3449-01, 0591-3449-30, 0591-3450-01, 0591-3450-30, 0591-3451-01, 0591-3451-30, 0591-3452-01, 0591-3452-30, 0591-3576-01, 0591-3576-30, 0591-3453-01, 0591-3453-30
Packager : Watson Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3449
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color YELLOW (Yellow Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code WATSON;3449;20;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3449-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3449-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011
Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3450
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color BLUE (Blue Violet Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code WATSON;3450;30;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3450-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3450-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011
Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3451
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color BLUE (Light Blue Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code WATSON;3451;50;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3451-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3451-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011
Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3452
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE60 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color PINK (Pink Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code WATSON;3452;60;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3452-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3452-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011
Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3576
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color BROWN (Flesh Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code WATSON;3576;80;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3576-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3576-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011
Morphine SulfateMorphine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3453
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SUCROSE(UNII: C151H8M554)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE BLACK(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
Product Characteristics
Color BLUE (Blue-Green Opaque Cap), WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code WATSON;3453;100;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3453-01100 in 1 BOTTLE, PLASTIC
2NDC:0591-3453-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200812 11/10/2011

PRINCIPAL DISPLAY PANEL

NDC 0591-3449-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
20 mg
Watson®    30 Capsules    Rx only

20 mg container label

PRINCIPAL DISPLAY PANEL

NDC 0591-3450-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
30 mg
Watson®    30 Capsules    Rx only

30 mg container label

PRINCIPAL DISPLAY PANEL

NDC 0591-3451-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
50 mg
Watson®    30 Capsules    Rx only

50 mg container label

PRINCIPAL DISPLAY PANEL

NDC 0591-3452-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
60 mg
Watson®    30 Capsules    Rx only

60 mg container label

PRINCIPAL DISPLAY PANEL

NDC 0591-3576-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
80 mg
Watson®    30 Capsules    Rx only

80 mg container label

PRINCIPAL DISPLAY PANEL

NDC 0591-3453-30
CII
Morphine
Sulfate
Extended-release
Capsules, USP
(Once or twice Daily Formulation)
100 mg
Watson®    30 Capsules    Rx only

100 mg container label